Model Number 1504-10-124 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994)
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Event Date 10/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Primary operative notes (b)(6) 2016 indicate the patient received a left total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and competitor cement was utilized.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2018 indicate the patient received a left total knee revision due to pain and loosening of the tibial component.Upon entering the joint, profound stiffness and significant adhesions were encountered and removed.The tibial component was noted to be loose at the cement to implant interface.Femur, insert and tibial component were revised.Depuy products were implanted along with competitor cement.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2016.Dor: (b)(6) 2018.Left knee.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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